Manufacturer registered with FDA
Premium Plus International Limited
Hong Kong, Hong Kong SAR China. Lists 17 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 60
- 510(k) clearances
- 32010–2017
- Markets registered in
- 656 registrations outside the US
- Establishments
- 1Hong Kong SAR China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Premium Plus International Limited as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Premium Plus International Limited | 3 clearances | 2010–2017 | Below |
| European Union | EUDAMED | Manufacturer | Premium Plus International Limited | 37 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Premium Plus International Ltd | 11 | 2008–2017 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Premium Plus International Limited | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PREMIUM PLUS INTERNATIONAL LIMITEDPremium Plus International Ltd. | 2 | 2015–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Premium Plus International Ltd | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Premium Plus International Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | DentmasDisposable Saliva Ejectors | 2007 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth mirrors, Intraoral Mirrors,mirrors | 2010 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | DentmasLED Curing LightModel C01Model C02Soleil 770 | 2016 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Premium PlusPro-Sys Hygiene HandpieceProphy Air Motor1002-4 | 2017 |
| Roll CottonEFN · Class 1 | — | Lister | Cotton Rolls | 2010 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental BrushesInterproximal brushes | 2020 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Atomo Dental Disposable Prophy AngleDentmasPREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | 2011 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | DentmasS-251 Prophy Cups, Screw-InS-M252 Prophy Cups, RA, Metal ShankT-251 Prophy Cups, Screw-InT-M252 Prophy Cups, RA, Metal ShankT-P252 Prophy Cups, RA, Plastic Shank18-250 Prophy Cups, Snap-On18-251 Prophy Cups, Screw-In18-M252 Prophy Cups, RA, Metal Shank18-P252 Prophy Cups, RA, Plastic Shank | 2007 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Finishing Strips single/double size coated | 2025 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | DentmasImpression Trays | 2007 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dentmas078 Curved Tip Syringes089 Impression Syringes | 2007 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | 2030 Intraoral Lippers2040 Intraoral Lippers2050A-2 Cheek Retractors2050C-2 Cheek Retractors2055A-2 Cheek Retractors2055C-2 Cheek Retractors2060 Intraoral Cheek Retractor2080 Intraoral Cheek Retractor2090 Mouth Props | 2007 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | DentmasPREMIUM HAND INSTRUMENTS | 2010 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophy Paste Cup Medium, Fine and Cup Holder | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | DENTAL BIBS PREMIUM PLUSDentmas/COTTON ROLLS | 2011 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Dentmas7800 Fluoride Trays7801 Fluoride Trays | 2007 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier FilmDentmasHandle SleevesHandpiece SleevesInstrument Tray SleevesLight/Sensor Sleeves/PouchesPremium Plus Barrier SleevesSyringe Sleeves | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Premium Plus International Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Oct 2017 | K170261 | Premium Plus Prophy Air Motor | EFB Dental Air-Powered Handpiece |
| 22 Aug 2016 | K153514 | Premium Plus C01/C02 LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 9 Dec 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Some of these clearances are listed with FDA today by another company: Jiangsu Yabaobao Medical Instrument Co.,Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Premium Plus International LimitedFDA reg. 3006847937 | Hong Kong, Hong Kong SAR China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023657). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.